Double-blind randomized, comparative multicenter study of the effect of terlipressin in the treatment of acute esophageal variceal and/or hypertensive gastropathy bleeding

Abstract

Background/aims: 1) To compare the effect of 2-day application of 0.2 mg terlipressin i.v. every 4 hours (group I) with that of 5-day application of 1 mg i.v. every 4 hours (group II) in the treatment of bleeding esophageal varices and portal gastropathy. 2) To assess the incidence of adverse events.

Methodology: Eighty-six patients with liver cirrhosis (54 men and 32 women, average age 51 years) were randomized over a period of 2 years into 2 groups. Acute bleeding was diagnosed endoscopically within 24 hours of its onset. The two groups fully comparable; treatment failure rated according to "Baveno II".

Results: Success rate in group I was 78% at day 2 and 75% at day 5; in group II 89% and 79%, respectively (no statistical significance). Rebleeding had occurred by day 5 in 15% in group I, and in 16.3% in group II. Transfusion needs by day 2 were significantly lower in group II (2.4 units compare to 3.4 units in I). The 30-day mortality was 17.1% in group I and 20% in group II. No statistical difference between I and II in the occurrence of adverse events.

Conclusions: At a dosage of 1 mg i.v. every 4 hours, the success rate at day 2 was as much as 90% while blood consumption was significantly lower compared with the lower dosage. Rebleeding during first 48 hours occurred almost exclusively at lower dosage. There was no increase in the rate of adverse events relative to the higher dosage.